Cimetidine 800mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Cimetidine

Disponible depuis:

Arrow Generics Ltd

Code ATC:

A02BA01

DCI (Dénomination commune internationale):

Cimetidine

Dosage:

800mg

forme pharmaceutique:

Oral tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 01030100

Notice patient

BEFORE YOU TAKE YOUR MEDICINE PLEASE READ THIS
LEAFLET CAREFULLY. This leaflet contains a summary of
the information about your medicine, Cimetidine Tablets. YOUR MEDICINE
Your medicine is in the form of a tablet. There are three
strengths of Cimetidine Tablets available, 200 mg, 400 mg and
800 mg. The 200 mg tablet contains 200 mg of the active
ingredient Cimetidine, whilst one 400 mg tablet contains
400 mg of active ingredient and one 800 mg tablet contains
800 mg of Cimetidine. Each tablet also contains sodium starch
glycollate, povidone, magnesium stearate, purified water,
microcrystalline cellulose (only found in 200 mg and 400 mg tablets),
maize starch (only
found in 200 mg and 400 mg tablets), E464, E171, E172, E132,
polyethylene glycol,
polyvinylpyrrolidone, hydroxypropylcellulose and carnauba wax.
Cimetidine Tablets 200 mg are available in blister packs of 60
tablets.
Cimetidine Tablets 400 mg are available in blister packs of 60
tablets.
Cimetidine Tablets 800 mg are available in blister packs of 30
tablets.
Your pharmacist will dispense the number of tablets prescribed by your
doctor.
Product Licence Holder and Manufacturer: Generics [UK] Limited,
Station Close, Potters Bar,
Herts, EN6 1TL. HOW DOES YOUR MEDICINE WORK ?
Your tablet contains Cimetidine, which helps to prevent the secretion
of acid from the
stomach. This means that these tablets can help treat conditions
characterised by too
much stomach acid, including ulcers of the small intestine,
non-cancerous gastric
(stomach) ulcers including those caused by non-steroidal
anti-inflammatory drugs,
recurrent ulcers and ulcers at the site of gastric surgery, reflux
oesophagitis (burning pain
in the gullet due to reflux of stomach acid). It can also help in the
treatment of persistent
dyspeptic (indigestion) symptoms with or without ulceration.
Cimetidine can also help
prevent bleeding from the stomach or duodenum due to stress ulcers in
seriously ill
patients; or prevent the aspiration of acid into the lungs in patients
about to receive
general anaest

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cimetidine 800 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Cimetidine Ph Eur 800 mg.
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablets.
Pale green, oval, film-coated tablet embossed with the company logo on
one face and
the code ‘276’ on the reverse, or plain on one side and embossed
with ‘276’ or ‘CIM
800’ or ‘CIMET 800’ on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cimetidine is a histamine H2-receptor antagonist which rapidly
inhibits both basal
and stimulated gastric secretion of acid and reduces pepsin output.
Cimetidine is indicated for the following:
1.
In the treatment of duodenal and benign gastric ulceration, including
that
associated with non-steroidal anti-inflammatory agents Recurrent and
stomal
ulceration and oesophageal reflux disease, and other conditions where
reduction
of gastric acid by cimetidine has been shown to be beneficial.
2.
In the treatment of persistent dyspeptic symptoms with or without
ulceration,
particularly meal-related upper abdominal pain, including such
symptoms
associated with non-steroidal anti-inflammatory agents.
3.
In the prophylaxis of gastro-intestinal haemorrhage from stress
ulceration in
critically ill patients.
4.
Before general anaesthesia in patients thought to be at risk of acid
aspiration
(Mendelson´s) syndrome, particularly obstetric patients during
labour.
5.
To reduce malabsorption and fluid loss in short bowel syndrome.
6.
To reduce degradation of enzyme supplements in pancreatic
insufficiency.
7.
In the management of Zollinger-Ellison syndrome.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The total daily dose should not normally exceed 2.4g. Dosage should be
reduced in
patients with impaired renal function. (see section 4.4).
_Adults_
The usual dosage is 400 mg twice a day with breakfast and at bedtime.
Alternatively
for patients with duodenal or benign gastric ulceration, a single